JOB TITLE: Clinical Research Coordinator I
REPORTS TO: Site Director Clinical Research
DEPARTMENT/LOCATION: Clinical, On-Site
JOB CLASSIFICATION: Permanent, Full-Time/Part-Time, Non-Exempt
REQUIREMENTS: Certified Medical Assistant Certificate
LAST MODIFIED: 7/9/2026
POSITION SUMMARY
The Clinical Research Coordinator I, will oversee and manage clinical research studies within the urology department and other current or future therapeutic areas as the research program expands. This role is responsible for patient-facing study coordination, protocol compliance, timely documentation, EDC data entry, query resolution, visit coordination, sponsor/CRO communication, and maintaining positive working relationships with investigators, clinic staff, vendors, sponsors, and peers.
ESSENTIAL FUNCTIONS
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Coordinate and manage clinical trials from initiation to close-out.
- Screen, recruit, and enroll study participants in accordance with protocol guidelines.
- Obtain informed consent and educate participants about study procedures.
- Maintain accurate and complete study documentation including source documents, case report forms, and regulatory binders in accordance with GCP, protocol requirements, and site processes.
- Monitor patient safety and report adverse events or protocol deviations.
- Respond to sponsor/CRO queries in a timely manner and proactively work to prevent aging queries.
- Prepare for monitoring visits, assist monitors during visits, and resolve monitoring findings or action items promptly.
- Perform or assist with phlebotomy, specimen collection, processing, handling, and shipment as required by protocol, site procedures, and IATA requirements.
- Collaborate with principal investigators, sponsors, and regulatory bodies.
- Collaborate effectively with other coordinators, research nurses, and clinical staff to ensure smooth patient handoffs, shared visit coverage, timely completion of protocol-required activities, and continuity of patient care.
- Maintain professional and effective relationships with patients, investigators, clinic staff, procedure teams, sponsors, CROs, vendors, and internal research team members.
- Prepare and submit IRB documents and ensure ongoing compliance.
- Collect, enter, and manage clinical data using electronic data capture systems.
- Schedule and track study visits, procedures, and follow-ups, and demonstrate flexibility in work hours when needed to accommodate clinic schedules, patient visit windows, and protocol-required procedures.
- Demonstrate adaptability and flexibility in a growing research program where studies, specialties, workflows, and responsibilities may evolve over time.
- Assist in grant applications, manuscript preparation, and presentations as needed.
- Perform other duties as assigned.
QUALIFICATIONS & REQUIREMENTS
To perform the job successfully, an individual should demonstrate the following competencies:
- Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Dependability - Follows instructions, responds to management direction; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
- Communication - Effectively communicates procedures and instructions to patients and healthcare team. Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Able to read and interpret written information.
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Change’s approach or method to best fit the situation.
- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Follows through on commitments.
- Analytical problem solving - Analyzes complex problems by gathering relevant data, identifying root causes, and developing effective logical solutions.
- Patient Focus - Demonstrates compassion, professionalism, and clear communication when interacting with study participants and families.
- Teamwork and Relationship Management - Maintains positive and professional working relationships with peers, investigators, clinic staff, sponsors, CROs, and vendors.
- Attention to Detail - Completes documentation, data entry, visit tracking, and regulatory tasks accurately and within required timelines.
- High School Diploma or equivalent. Bachelor’s Degree preferred.
- Certified Medical Assistant Certificate and/or graduation from an accredited program for medical assistants is required.
- Knowledge of FDA regulations, ICH-GCP guidelines, and HIPAA compliance.
- Strong organizational and communication skills.
- Proficiency in Microsoft Office and clinical trial management systems.
- Certification in clinical research (e.g., ACRP or SOCRA) preferred.
- Experience with multicenter trials and industry-sponsored studies.
- Familiarity with urologic conditions and procedures.
- Phlebotomy training, knowledge, or experience required; certification is preferred where applicable.
- Prior patient-facing clinical experience preferred.
- Ability to work independently and manage multiple studies simultaneously.
WORKING ENVIRONMENT
This role is based in a fast-paced, and evolving clinical research environment with changing study priorities, sponsor expectations, and workflow needs. The noise level is moderate, typical of a busy clinic and is clean, well-lit and ventilated. There is potential exposure to biohazardous materials, communicable diseases and radiation. You may share the workspace with other coordinators or research staff. Work hours may vary based on clinic schedules, patient visit windows, and protocol required study activities. Flexibility in scheduling is expected when needed, with prior approval from the supervisor when applicable. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee is often required to stand/walk for extended periods (4-6 hours/day) during the workday. The employee must lift/carry equipment or assist patients (up to 50 + lbs.) Exposure to stress due to safety, accuracy, and patient care demands. Prolonged computer use, including use of computer screens, keyboard, mouse, EDC systems, CTMS/eSource systems, email, and electronic medical records.
COMPANY OVERVIEW
OUR MISSION: To provide compassionate, world-class urologic care and exceptional experiences for our patients, employees and partners.
OUR VISION: Curing the world of urologic disorders, one person at a time.
OUR VALUES: At UCI, we are passionate about patient experience and making the healthcare journey from diagnosis through treatment as easy and stress-free as possible! Through unmatched integration and access for patients, partner hospitals and other physicians in the community, we provide world-class urologic care in an attentive environment where you are at the center of all we do.
